Quality Systems Specialist

The Cretex Companies; Brooklyn Park (MN); On-site; USD 62,000 - 93,000; Full time

Job summary

Cretex Medical in Minnesota seeks a Quality Systems Specialist to develop, implement, and maintain a scalable quality management system across the organization, ensuring compliance with ISO 13485:2016 and FDA requirements. You will participate in audits, drive CAPA programs, and partner with quality and operations to elevate process excellence.

The role requires 3+ years in quality management, a related degree, and Lead Auditor certification, plus willingness to travel up to 15%.

Qualifications

• Bachelor’s degree in a related field or equivalent relevant experience.
• 3 years of experience with quality management systems.
• Experience with ISO 13485:2016 and FDA.
• Lead Auditor Certification.
• Ability to travel up to 15%.

Responsibilities

• Assist or lead audits (second/third party), including prep, execution, reporting, and follow-up.
• Manage or lead internal audits and implement corrective actions.
• Perform process and product audits to identify gaps and drive lean improvements.
• Maintain a scalable Global Quality System model and CAPA program.
• Support ISO and medical device regulatory compliance and training.

Skills

Lead Auditor Certification

Project management

Microsoft Office proficiency

Clear verbal and written communication

Attention to detail

Organizational skills

Teamwork in fast-paced environment

Travel readiness up to 15%

Quality management systems experience

ISO 13485:2016 and FDA knowledge

Education

Bachelor’s degree in a related field or equivalent relevant experience

Tools

ISO 13485 & FDA process knowledge

Job description

Overview

About Cretex Medical

Cretex Medical is a leading contract manufacturer of precision components and assemblies for the medical device industry. Our customers view us as a trusted partner in the areas of injection molding, laser processing, metal stamping and device assembly. Learn more at www.cretexmedical.com.

Position Summary

The Quality Systems Specialist will be responsible for developing, implementing, and maintaining the quality management system.

Responsibilities

• May assist or lead second and third-party audits, including audit preparation, execution, reporting and follow-up activities
• May manage or lead the internal audit including implementation of effective corrective actions.
• Perform process and product audits to identify gaps and deficiencies and implement process improvement initiatives utilizing lean techniques
• Assist in maintaining a Global Quality System model that scales with organizational growth
• Implement, monitor, lead and assist Corrective and Preventive Actions (CAPAs) that result from second, third-party, and internal audits.
• Assist in maintaining relevant QMS training programs to promote quality awareness and ensure compliance to company policies and procedures
• Partner with quality and operations to implement quality system improvements
• Support and comply with the company Quality System, ISO, and medical device requirements
• Read, understand, and follow work instructions and standard work
• Partner with other business segments: sales/marketing, customer service, engineering, quality, and finance
• Understand customer needs and the core business markets we serve
• Ensure business systems are implemented, maintained, and functioning properly
• Participate in required company meetings
• Maintain an organized work area (5S)
• Participate in the Operational Excellence Program
• Complete all other work duties as assigned

Qualifications

• Bachelor’s degree in a related field or equivalent relevant experience
• 3 years of experience working with quality management systems
• Experience with ISO 13485:2016 and FDA
• Lead Auditor Certification
• Ability to consistently achieve short and long term business results
• Ability to prioritize work and manage multiple tasks when needed
• Ability to follow through on commitments and hold team members accountable
• Consistently produces work that meets the customer’s requirements
• Focus on Operational Excellence
• Project management skills
• Microsoft Office proficiency (Outlook, Word, Excel, PowerPoint, Publisher)
• Clear and effective verbal and written communication skills
• Attention to detail
• Organizational skills
• Ability to work in a fast-paced team environment
• Ability to prioritize and multitask
• Ability to work in a manufacturing environment
• Ability to travel up to 15%

Desired Criteria

• Quality systems experience in a manufacturing setting
• Continuing education; including participation in local chapters, associations, and/or organizations

What is it like to work at Cretex Medical?

We recognize the contribution of every individual and promote growth, safety and security for all our employees. Cretex Medical values performance and pays competitive wages along with a rich benefit package. We offer a positive work environment with a focus on continuous improvement.

Here are some of things that employees have said about working for Cretex Medical:

• “The culture at Cretex is collaborative. Everyone here is willing to help you whether it is a director, a machinist, or your boss. Everyone is always willing to help you figure out a project and get it done right.”
• “I would tell potential interns that Cretex is a great company to work for. It has set a high bar for corporate culture as well as the quality of work you can do. I would definitely recommend it.”
• “I learned that I really like the medical device industry. The importance and the gravity of what we do here is felt by the employees. You can have that passion in your work because you know what you are striving for is to save lives.”

We encourage you to explore the many opportunities Cretex Medical can offer you as a valued team member.

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Pay Range

USD $62,000.00 - USD $93,000.00 /Yr.

Pay Range Details

This pay range reflects the base hourly rate or annual salary for positions within this job grade, based on our market-based pay structures. Actual compensation will depend on factors such as skills, relevant experience, education, internal equity, business needs, and local market conditions. While the full hiring range is shared for transparency, offers are rarely made at the minimum or maximum of the range

Company Benefits

All Employees:

Our 401k retirement savings plan with a company match contribution; onsite health clinics, discretionary holiday bonus program (based on years of service), Cretex University, 24/7 employee assistance program with access to five confidential visits with a licensed counselor at no cost, wellness program with incentives, an employee death benefit, and employee sick and safe leave are available to all Cretex employees.

20+hours:

Cretex’s medical benefit package includes: comprehensive medical insurance with access to virtual providers; dental insurance (Little Partners Dental benefit covers services 100 percent for children 12 and younger when seen by a Health Partners in network provider); vision insurance; a pre-tax health savings account, healthcare and dependent care pre-tax reimbursement accounts; paid holidays, paid time off; and our discretionary profit sharing program are available to employees working 20+ hours/week.

30+ hours:

Parental Leave, accident and critical illness benefits, optional employee, spouse, and child life; short and long term disability; company provided life insurance; and tuition assistance programs are available to employees working 30+ hours per week.

(Some benefits are subject to eligibility criteria.)

Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, gender identity, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Our company uses E-Verify to confirm the employment and eligibility of all newly hired employees. To learn more about E-Verify, including your rights and responsibilities, please visit www.dhs.gov/E-Verify.